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Active, Not Recruiting

NCT Number: NCT07494175

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
  • Male participants aged between 18 and 45 years old (inclusive);
  • ASA =I;
  • Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
  • Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

Exclusion criteria

  • Participants with a history of or current acute or chronic clinical diseases
  • Participants with a history of neuromuscular diseases;
  • Participants with a history of anesthetic complications;
  • Participants with a history of airway diseases;
  • Participants who have undergone major surgery within 6 months prior to screening;
  • During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
  • Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
  • Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
  • Participants with contraindications to anesthetic agents;
  • Participants who use hepatic enzyme inhibitors/inducers (within 1 month prior to dosing), vaccines (within 1 month pre-screening or planned during trial), or any drugs/health products (within 7 half-lives or 14 days pre-dosing);
  • Participants who have participated in other clinical trials and received investigational products within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
  • Participants with history of significant blood loss/transfusion (≥400 mL within 3 months), active tobacco (>5 cigarettes/day), excessive alcohol/coffee consumption, use of interfering substances (e.g., grapefruit, caffeine) within 48h prior to dosing, or evidence of drug abuse;
  • Participants with difficult venous access;
  • Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
  • Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.

Treatment and study plan

[14C] HRS-9190

Drug

[14C] HRS-9190 for injection

Primary outcomes

  1. Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta

    Time frame: From 0 to 120 hours after dosing

  2. Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma

    Time frame: From 0 to 120 hours after dosing

  3. Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose

    Time frame: From 0 to 120 hours after dosing

  4. List of metabolites identified in plasma, urine, and feces

    Time frame: From 0 to 120 hours after dosing

  5. Total radioactive pharmacokinetic parameter Tmax

    Time frame: From 0 to 120 hours after dosing

  6. Total radioactive pharmacokinetic parameter Cmax

    Time frame: From 0 to 120 hours after dosing

  7. Total radioactive pharmacokinetic parameter t1/2

    Time frame: From 0 to 120 hours after dosing

  8. Total radioactive pharmacokinetic parameter MRT

    Time frame: From 0 to 120 hours after dosing

  9. Total radioactive pharmacokinetic parameter AUC

    Time frame: From 0 to 120 hours after dosing

  10. The whole blood-plasma radioactive distribution ratio

    Time frame: From 0 to 120 hours after dosing

Secondary outcomes

  1. Adverse events

    Time frame: up to 13 days postdose

  2. Plasma concentration of HRS-9190 (metabolites, if necessary)

    Time frame: From 0 to 120 hours after dosing

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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